LUT014 for the Treatment of Radiation Induced Dermatitis in Breast Cancer Patients (NCT04261387) | Clinical Trial Compass
CompletedPhase 1/2
LUT014 for the Treatment of Radiation Induced Dermatitis in Breast Cancer Patients
United States28 participantsStarted 2021-01-30
Plain-language summary
The study will evaluate the safety, tolerability and efficacy of LUT014 gel topically administered in breast cancer patients who developed radiation dermatitis. Subjects enrolled to part 1 will be enrolled to receive the study treatment (open label treatment) for 28 days and will be followed up for 2 months after the completion of study treatment. Subject in Part 2 will be randomized in 1:1 ratio to receive either the study drug or placebo (double-blind treatment) for qd topical application for 28 days and will be followed up for 2 months after the completion of study treatment.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Female subjects diagnosed with stage Tis, T0-T3, N0-N2, M0 Breast Cancer;
✓. Subject is ≥18 years at the time of signing the informed consent form (ICF);
✓. Radiation dermatitis of Grade 2, based on the NCI CTCAE at the Screening and Baseline (D0) visits;
✓. Completed fractionated radiation therapy for breast prior to first dose of study drug (Day 0);
✓. A score of ≥ 6 reported in the Dermatology Life Quality Index at the Screening and Baseline Visits;
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
✓. Females of child-bearing potential must have a negative pregnancy test at screening and must agree to use an effective contraception method\* or abstain from sex throughout the study until Day 83;
✓. Expected life expectancy greater than 6 months
Exclusion criteria
✕. Bilateral breast irradiation;
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE (Part 1 subjects)
Timeframe: 12 weeks (83 days)
2
Change in the severity of radiation dermatitis based on self reporting Dermatology QoL questionnaire (Part 2 subjects)
✕. Planned internal mammary node irradiation with electrons. Planned photon coverage of internal mammary chain nodes is acceptable for inclusion in this study;
✕. Planned partial breast accelerated irradiation;
✕. Any cutaneous infection or significant skin disease at Screening or Baseline (Day 0) other than the dermatitis in the area(s) irradiated during fractionated radiation therapy;
✕. T4 breast cancer or direct skin involvement by breast cancer;
✕. Breast implants or underwent breast reconstruction;
✕. Any cancer other than breast cancer within 3 years of Screening, except for carcinoma in situ of the cervix;